Design Validation
Design Validation is a required step in medical device development that ensures a product works correctly and safely for its intended use. Think of it as a thorough checking process where companies prove their medical device does what it's supposed to do in real-world conditions. This is different from Design Verification (which tests if the product meets technical requirements) because Validation focuses on testing with actual users and real-world scenarios. It's a crucial part of getting medical devices approved by regulators like the FDA.
Examples in Resumes
Led Design Validation testing for Class II medical devices following FDA guidelines
Managed Design Validation and Design Validation Testing protocols for new surgical instruments
Developed and executed Design Validation studies involving end-user feedback for diagnostic equipment
Typical job title: "Design Validation Engineers"
Also try searching for:
Where to Find Design Validation Engineers
Professional Organizations
Online Communities
Job Resources
Example Interview Questions
Senior Level Questions
Q: How would you develop a design validation plan for a new medical device?
Expected Answer: A senior candidate should explain how they would identify the intended use, create test protocols that simulate real usage, involve actual end users, and ensure compliance with FDA requirements. They should mention risk management and documentation practices.
Q: How do you handle design validation failures?
Expected Answer: They should discuss the process of investigating root causes, documenting issues, implementing corrective actions, and potentially redesigning aspects of the product. Should mention the importance of communication with stakeholders and regulatory implications.
Mid Level Questions
Q: What's the difference between design verification and design validation?
Expected Answer: Should explain that verification checks if the product meets technical specifications, while validation ensures it meets user needs in actual use conditions. Should provide simple examples.
Q: How do you document design validation results?
Expected Answer: Should describe the importance of thorough documentation, mention test protocols, acceptance criteria, results recording, and the need for proper sign-offs and regulatory compliance.
Junior Level Questions
Q: What is the purpose of design validation?
Expected Answer: Should explain that it's to ensure the medical device works safely and effectively for its intended use, and mention that it involves testing with actual users.
Q: What types of documents are involved in design validation?
Expected Answer: Should mention test protocols, user requirements, validation plans, test reports, and regulatory documentation. Basic understanding of documentation requirements is sufficient.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of FDA requirements
- Assisting with validation testing
- Documentation preparation
- Following test protocols
Mid (2-5 years)
- Creating validation protocols
- Managing validation studies
- Risk analysis participation
- User requirement development
Senior (5+ years)
- Full validation program management
- FDA compliance strategy
- Team leadership
- Risk management expertise
Red Flags to Watch For
- No knowledge of FDA or regulatory requirements
- Lack of documentation experience
- No understanding of medical device development process
- Unable to explain difference between verification and validation
Related Terms
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